Drug profile
Vonoprazan
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Recommended Dosage : Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6
months.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.1 ) Relief of Heartburn Associated with Non-Erosive Gastroesophageal Reflux
Disease: 10 mg once daily for 4 weeks.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- The safety and effectiveness of VOQUEZNA have not been established in pediatric
patients.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'pediatric use', retrieved
2026-08-29
- Recommended Dosage : Healing of Erosive Esophagitis: 20 mg once daily for 8 weeks.
( 2.1 ) Maintenance of Healed Erosive Esophagitis: 10 mg once daily for up to 6
months. ( 2.1 ) Relief of Heartburn Associated with Non-Erosive Gastroesophageal
Reflux Disease: 10 mg once daily for 4 weeks. ( 2.1 ) Treatment of H. pylori
Infection: see full prescribing information.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'dosage and
administration', retrieved 2026-08-29
- Table 4: Recommended VOQUEZNA Dosage in Patients with Hepatic Impairment:
Treatment of H. pylori Infection Classification Recommended Dosage Child-Pugh
Class A 20 mg twice daily Child-Pugh Class B Use is not recommended Child-Pugh
Class C Use is not recommended 2.4 Administration Instructions Take VOQUEZNA with
or without food [see Clinical Pharmacology (12.3) ] .
Source: This line points to a numbered table that this card does not show - read
that table in the label before you dose. US FDA label for vonoprazan (VOQUEZNA),
section 'dosage and administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- Also refer to the amoxicillin and clarithromycin full prescribing information. 2.2
Recommended Dosage in Patients with Renal Impairment Healing of Erosive
Esophagitis The recommended dosage of VOQUEZNA in adult patients with renal
impairment is described in Table 1 below [see Use in Specific Populations (8.6)
and Clinical Pharmacology (12.3) ] .
Source: This line points to a numbered table that this card does not show - read
that table in the label before you dose. US FDA label for vonoprazan (VOQUEZNA),
section 'dosage and administration', retrieved 2026-08-29
- Treatment of H. pylori Infection The recommended dosage of VOQUEZNA in adult
patients with renal impairment is described in Table 2 below [see Use in Specific
Populations (8.6) and Clinical Pharmacology (12.3) ].
Source: This line points to a numbered table that this card does not show - read
that table in the label before you dose. US FDA label for vonoprazan (VOQUEZNA),
section 'dosage and administration', retrieved 2026-08-29
- Table 2: Recommended VOQUEZNA Dosage in Patients with Renal Impairment: Treatment
of H. pylori Infection Also refer to the Dosage and Administration section of the
amoxicillin and clarithromycin prescribing information for dosage recommendations
in patients with renal impairment.
Source: This line points to a numbered table that this card does not show - read
that table in the label before you dose. US FDA label for vonoprazan (VOQUEZNA),
section 'dosage and administration', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- ( 2.1 ) See also full prescribing information for the recommended dosage by
indication for patients with renal or hepatic impairment.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'dosage and
administration', retrieved 2026-08-29
- Estimated GFR Recommended Dosage 30 mL/minute or greater 20 mg twice daily Less
than 30 mL/minute Use is not recommended 2.3 Recommended Dosage in Patients with
Hepatic Impairment Healing of Erosive Esophagitis The recommended dosage of
VOQUEZNA in adult patients with hepatic impairment is described in Table 3 below
[see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ] .
Source: This line points to a numbered table that this card does not show - read
that table in the label before you dose. US FDA label for vonoprazan (VOQUEZNA),
section 'dosage and administration', retrieved 2026-08-29
- Treatment of H. pylori Infection The recommended dosage of VOQUEZNA in adult
patients with hepatic impairment is described in Table 4 below [see Use in
Specific Populations (8.7) and Clinical Pharmacology (12.3) ].
Source: This line points to a numbered table that this card does not show - read
that table in the label before you dose. US FDA label for vonoprazan (VOQUEZNA),
section 'dosage and administration', retrieved 2026-08-29
PREGNANCY
- Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors
pregnancy outcomes in women exposed to VOQUEZNA during pregnancy.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'pregnancy', retrieved
2026-08-29
- Healthcare providers are encouraged to register patients by calling 1-866-609-1612
or visiting https://voqueznapregnancyregistry.com/ .
Source: US FDA label for vonoprazan (VOQUEZNA), section 'pregnancy', retrieved
2026-08-29
- Risk Summary There are no adequate and well-controlled studies of vonoprazan in
pregnant women.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'pregnancy', retrieved
2026-08-29
BREASTFEEDING
- In a pre- and postnatal development (PPND) study, pups from dams orally
administered vonoprazan during organogenesis and through lactation exhibited liver
discoloration, which, in follow-up mechanistic animal studies, was associated with
necrosis, fibrosis, and hemorrhage at a dose approximately 22-times the MRHD,
based on AUC comparisons that were likely attributable to exposure during
lactation [see Use in Specific Populations (8.2) ] .
Source: US FDA label for vonoprazan (VOQUEZNA), section 'use in specific
populations', retrieved 2026-08-29
- In a PPND study, pregnant female rats were orally administered vonoprazan at doses
of 1, 3, 10, or 100 mg/kg/day (0.01-, 0.18-, 1.1-, 22-times the MRHD based on AUC
comparison) from GD 6 to lactation day (LD) 21.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'use in specific
populations', retrieved 2026-08-29
- Decreased body weight gain and food consumption were present in dams at the
highest dose during lactation.
Source: US FDA label for vonoprazan (VOQUEZNA), section 'use in specific
populations', retrieved 2026-08-29